ORal IrON Supplementation With Ferric Maltol in Patients With Heart Failure Carrying Left Ventricular Assist Devices

NCT ID: NCT03774615

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2019-11-29

Brief Summary

This is a open-label, uncontrolled, monocenter, phase IV study. The aim of this study is to detect AEs or SAEs with a relative frequency of at least 11.5% in LVAD patients with iron deficiency anemia treated with oral ferric maltol for 12 weeks.

Conditions

Heart Failure, Left Sided; Anemia, Iron Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric maltol 30 mg (Feraccru®)

Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks

Group Type: EXPERIMENTAL

Ferric maltol 30 mg (Feraccru®)

Intervention Type: DRUG

Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Interventions

Ferric maltol 30 mg (Feraccru®)

Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures

2. Male and female patients ≥18 years at day of inclusion

3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial

4. Patients that have an LVAD implanted for chronic heart failure and which are clinically stable for at least 6 months after LVAD implantation in the opinion of the investigator

5. 6 min walk distance >50 m

6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening

7. Women of childbearing potential must:

Have a negative pregnancy test at screening Agree to use reliable methods of contraception during the course of the study

Exclusion Criteria

1. Active hematological disorders other than iron-deficiency anemia

2. Other medical condition that according to the investigator's assessment is causing or contributing to anemia

3. Active malignancy

4. Active infectious disease

5. Active bleeding

6. Severe renal insufficiency (requiring dialysis)

7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l

8. Ongoing oral or intravenous iron supplementation

9. Concomitant erythropoietin medication

10. Pregnancy or lactation period

11. Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study.

12. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product

13. Known haemochromatosis or other iron overload syndromes

14. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shields, Shields and Associates

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Schmitto, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Medizinische Hochschule Hannover, Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie (HTTG)

Hanover, , Germany

Countries

Germany

Other Identifiers

ORION-LVAD-1

Identifier Type: -

Identifier Source: org_study_id